Status:
NOT_YET_RECRUITING
Investigation of Mnesic Capacities in Patients With a Disorder of Consciousness
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Institut du Cerveau et de la Moelle (ICM Institute)
Conditions:
Disorders of Consciousness
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
Following severe brain damage, some individuals lose partial or total awareness of themselves and their environment, falling into a coma that can evolve towards a Disorder of Consciousness (DoC). Accu...
Detailed Description
This study investigates the memory capacities of Intensive Care Unit patients suffering from a Disorder of Consciousness (DoC) resulting from severe brain injury. Given the complexity of human memory,...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients suffering from a Disorder of Consciousness:
- Patient not conscious according to the CRS-R scale (Kalmar \& Giacino, 2005)
- Age over 15 years and 3 months
- Free and informed consent signed by a third party (parental authority, trusted support person)
- Conscious patients (controls) :
- Age over 15 years and 3 months
- Cared for in an Intensive Care Unit
- Free and informed consent signature
- Patients who have regained consciousness after having suffered from a Disorder of Consciousness (if not included during their disorder):
- Age over 15 years and 3 months
- Free and informed consent signature if able, otherwise signature of relative (holders of parental authority for minors)
- Patient who has been unconscious for at least 3 days according to the CRS-R scale Exclusion criteria: - Deep sedation (Intracranial hypertension, refractory status epilepticus)
- Previous severe neurodegenerative disease (e.g. Alzheimer's disease, Lewy body dementia)
- Deafness
- Patients under guardianship or trusteeship
- Pregnant and breast-feeding women
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06959212
Start Date
June 1 2025
End Date
August 1 2030
Last Update
May 6 2025
Active Locations (2)
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1
APHP, Pitié-Salpêtrière Hospital, Department of Anesthesia and Intensive Care, NeuroSurgery ICU
Paris, France, 75013
2
APHP, Pitié-Salpêtrière Hospital, Department of Neurology, Neuro-ICU
Paris, France, 75013